Six Sigma Project Report

Six Sigma Project Report

Yield Improvement of Betnesol Tablets using DMAIC Approach

Under the Guidance of

Company Guide Faculty Guide

Mr Kapil Agarwal Mrs. Mrunalini Dodkey

General Manager, Value Stream Lead Faculty - SIOM, Nashik

Submitted by:

Swachchhatoa Hore

PRN: 14020741088

Table of Contents

Student Declaration 4

Preface 5

List of abbreviations 7

List of Tables 8

List of Figures 9

Acknowledgement 10

Executive Summary 11

1. Introduction 12

2. Literature Review 13

3. Background of Industry 15

4. Company background and growth 17

4.1 Major Strategic aspects 17

4.2 GSK Nashik 18

4.3 Tablet Manufacturing 19

4.4 Need / Justification for the Project 31

5. Research Methodology 32

Within the pharmaceutical industry, there are various IT factors when transitioning from an existing management process to a new one. The Six Sigma quality improvement theory allows businesses to continuously improve and change the industry in a positive direction. Because this process is so complex, businesses requires interoperable and flexible systems that enable information to pass across the entire business. Within the pharmaceutical industry, mining data and interpreting it both seamlessly and quickly are very important aspects of Six Sigma. With the help of this methodology’s tools and theories, information is able to be transformed into data that can be used to outperform the competition. The pharmaceutical industry has been one of the last to implement a quality management procedure like Six Sigma. In this industry there is a great need for productivity and efficiency. The reason behind the late insertion within the manufacturing aspect of the industry is due to the burden and cost in revalidating processes. Once a manufacturer has validated a process and made it compliant, they are naturally reticent to changes. Various drug manufacturers have had no real economic incentive implemented which would have them change their processes. Six Sigma methodologies have made noticeable changes within other industries such

Pharmaceutical industry is the most regulated of all industries. Regulatory affairs professionals are key players in the product development and as communication link between the industry and agencies. Six Sigma as a problem solving approach has been used in various fields to provide the fundamentals of variation management and reduction in order to assist in transforming established methodologies into new and efficient techniques. The study says Six Sigma concept is desirable in this scenario to understand the critical processes to new drug development and to research and streamline existing ones. It is important to have these objectives to reduce drug failures, effect maximum utilization of resources, and increase productivity and optimum utilization of staff and other resources.

2. Six Sigma: A Retrospective and Prospective Study

Weiyong Zhang, Arthur V. Hill, Glenn H. Gilbreath

This paper first reviewed the current literature on Six Sigma, and then performed a critical analysis of Six Sigma in light of the management literature. The review and analysis suggested that Six Sigma is best defined as a new approach to quality management. Consequently, Six Sigma provides an interesting context for a number of research questions. It then discussed these prospective research questions. This study lays a foundation for future research on Six Sigma.

3. A Review: Six Sigma Implementation